Piloting Virtual Reality Environments to Treat PTSD in Healthcare Workers

NCT04887116 | Recruiting Early Phase 1

• 1 other identifier: 20-04021926
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Healthcare workers and COVID-19 patients may experience psychological distress consequent to the pandemic, and are at particularly elevated risk for experiencing posttraumatic stress disorder (PTSD), based on evidence from previous infectious disease outbreaks. The best-validated treatment for PTSD is exposure therapy. Exposure therapy help patients suffering from PTSD to revisit and overcome their traumatic experiences. Including virtual reality in exposure therapy has a long history in treating PTSD; and has been used to treat military veterans and first-responders following 9/11. The investigators are developing and testing a virtual environment to treat PTSD including sub threshold PTSD symptoms in HCWs who experience occupational related trauma (e.g., working with COVID-19 patients) and COVID-19 patients. An independent evaluator will assess symptoms of PTSD and other psychopathology, using structured clinical interviews and self-report measures with well-established psychometric properties, at baseline, halfway through treatment, after completion of treatment, and at three-months post-treatment. Participants will complete ten ninety minute sessions (in-person or remotely), twice a week for five weeks aimed at mitigating their symptoms of PTSD. Remote participants will receive VR headsets after the baseline assessment and will keep them for the duration of the study. The pilot study will aim to demonstrate the feasibility and the tolerability of the virtual reality intervention in these populations.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; Virtual reality; VR; Healthcare workers; COVID-19; Pandemic

Outcome Measures

Primary Outcomes (5)

• Change in Clinician Administered PTSD Score (CAPS-V)

  Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-V) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.

  Baseline to approximately five weeks

• Feasibility Indicator: Recruitment

  Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.

  Baseline

• Feasibility Indicator: Enrollment

  Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.

  Baseline

• Feasibility Indicator: Retention

  Feasibility assessment will include retention defined as the number of participants completing the full intervention.

  Post-Treatment Assessment at approximately 5 weeks

• Acceptability Indicator: Satisfaction

  Acceptability and treatment satisfaction will be rated with a Likert scale.

  Post-Treatment Assessment at approximately 5 weeks

Secondary Outcomes (10)

• Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale

  Baseline to approximately five weeks

• Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomatology

  Baseline to approximately five weeks

• Change in score on the Insomnia Sleep Index

  Baseline to approximately five weeks

• Change in score on the PTSD Checklist for DSM-5 (PCL-5)

  Baseline to approximately five weeks

• Change in Score on the Occupational Stress Inventory Revised (OSI-R)

  Baseline to approximately five weeks

Study Arms (1)

Virtual Reality Exposure Therapy

EXPERIMENTAL

Virtual Reality Exposure Therapy

Behavioral: Virtual Reality Exposure Therapy

Interventions

Virtual Reality Exposure Therapy BEHAVIORAL

Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks, either remotely or in person.

Virtual Reality Exposure Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A COVID-19 patient or any healthcare worker providing medical care or support who experiences occupational-related trauma
• English-speaking
• Age ≥18
• Medically stable
• Diagnosed with PTSD or sub threshold PTSD
• Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
• Stable on psychotropic medication for the prior 60 days

You may not qualify if:

• Current significant unstable medical illness such that the participant could not attend sessions regularly or complete assessments
• Patients who in the investigator's judgment pose a current homicidal, suicidal or other risk
• Lifetime or Current diagnosis of schizophrenia or other psychotic disorder
• Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months
• History of motion sickness or seizures

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Cornell University: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; COVID-19

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• JoAnn Difede, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle McLeod Daphnis, BS

CONTACT

3108256016; sum4009@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 14, 2021
• Study Start: October 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)